Supplier Audits and Management

Why Should You Attend:

Inadequate supplier/purchasing control can lead to a multitude of problems including rejections or delays at receiving inspection; non-conformances and scrap on your manufacturing lines; and quality problems that can manifest later in the field resulting in MDRs and recalls.

Supplier management requires clear information about your supplier’s strengths and weaknesses and capability to consistently meet your requirements. And without an effective suppler audit program, supplier management lacks awareness of the issues within their suppliers. Management is blind to the problems with their suppliers and the risk that poses.

However, many companies conduct audits only because they are required to by regulation. Businesses often see supplier audit as a non-value added activity leading to meaningless findings, bureaucracy, and cumbersome processes. And despite having supplier audit program, management is often surprised by quality problems. This webinar can help you to avoid these problems.

Learning Objectives:

• Responsibilities for supplier management and purchasing controls
• Balance between supplier management and receiving inspection
• Enforcement case studies and lessons learned
• Quality agreements
• Using a structured program to identify areas of risk leading to an effective audit strategy
• How to develop a meaningful structure of oversight, audit, transparent communication, and escalation to management review
• Audit planning, execution, and follow-up
• How to ensure management gets valuable information from your audit program.

Areas Covered in the Webinar:

This 90-minute webinar will include:

• Understanding the regulations and expectations
• Lessons Learned
• Purchasing Controls Process
• Planning
• Evaluation of Suppliers
• Audit of Suppliers
• Balance between purchasing control and receiving inspection
• Performance Management
• Feedback and Communication
• Best Practices
• Inspection Readiness

Who Will Benefit:

• Supplier Engineers
• Supplier Auditors
• Supplier/Purchasing Managers
• Quality Engineers
• Supplier Quality Engineers
• Compliance Personnel
• Compliance Specialists
• Quality/Compliance managers or directors for Medical Device companies
• General Managers wanting to learn how to Management Review and expectations

Susanne Manz
President and Principal Consultant, Manz Consulting Inc

Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, Worldwide Director of Quality Engineering, Design Quality, and Director of Corporate Compliance. She has traveled extensively throughout the world helping companies understand and improve their Quality Management Systems. Susanne is a Presidential Scholar and has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and is a Certified Quality Auditor by the American Society for Quality. She has also served as a judge for the ASQ ITEA awards. Susanne has now established a consulting business, Manz Consulting LLC, with a mission to provide services to help medical device companies achieve world-class quality and compliance.Susanne’s new book on Medical Device Quality Management Systems – Strategies and Techniques for Improved Efficiency and Effectiveness, is now available on Elsevier and Amazon.

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